Neoplasms

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

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Genital Neoplasms, Male

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Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

HDR brachytherapy of 27 Gy delivered in 2 fractions one week apart

HDR brachytherapy of 19 Gy delivered in a single fraction

High dose-rate brachytherapy using real-time intra-operative transrectal ultrasound guidance. Patients will receive 27 Gy as a minimal Clinical Target Volume (CTV) dose delivered as two fractions of 13.5 Gy 7-13 days apart. The CTV is the ultrasound defined prostate with a 0-2 mm margin.

HDR 2 Fraction

High Dose-Rate Brachytherapy delivered in same manner as Arm 1, but to a prescribed CTV minimal dose of 19 Gy in a single fraction

HDR 1 Fraction

Gerard Morton, MD

A single high dose rate brachytherapy (HDR) treatment combined with a short course of external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men with intermediate risk prostate cancer. High cancer control rates have also been reported with HDR used on its own, without the EBRT. The challenge has been to determine what HDR dose to use with a move towards one or two fractions by several investigators. These schedules are reported to be well tolerated in the short term, but with little long term data. The objective of this study is to investigate HDR monotherapy given as either one fraction of 19 Gy or two fractions of 13.5 Gy in a randomized phase II clinical trial. The primary endpoint is patient reported toxicity and health related quality of life at 1 year, and efficacy data will be also be analyzed. Sample size for the study is 174 patients, which we expect to accrue within 18 months.

A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer

A Randomized Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer

To demonstrate that health related QoL at 1 year in the urinary and bowel domains of the Expanded Prostate Index Composite (EPIC) for at least one HDR monotherapy arm is not worse than that following current standard treatment with single fraction HDR combined with supplemental external beam radiotherapy.

To determine genito-urinary (GU) and gastro-intestinal (GI) toxicities in both study arms according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0

To determine changes in urinary symptoms in both study arms as determined by the International Prostate Symptom Score (IPSS)

To determine changes in serum prostate-specific antigen (PSA) in both arms

To determine PSA failure and disease free survival rates in both study arms

To determine changes in erectile function in both study arms assessed using the International Index of Erectile Function (IIEF) scale

To explore association between dosimetric parameters and toxicity/EPIC domain change

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer	NCT01890096	Carcinoma of th...	HDR 2 Fraction HDR 1 Fraction	18 Years -	Sunnybrook Health Sciences Centre
A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer	NCT01890096	Carcinoma of th...	HDR 2 Fraction HDR 1 Fraction	18 Years -	Sunnybrook Health Sciences Centre

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